This invention relates to an improvement to the design of a nasal dilator that is described in Spanish Patent No. 289,561 for Orthopaedic Adhesive granted to Miguel Angel Aviles Iriarti on 15 Sep. 1986. The Iriarti patent describes two designs of a nasal dilator. The first consists of a resilient band which has an adhesive on the bottom side and sufficient length so that when the center of the resilient band is bent over the bridge of the nose, each end is attached to the soft tissue on the lateral wall of the nasal passage. The adhesive can be applied as part of the back of the resilient band or applied directly to the skin prior to the application of the resilient band.
The second design described in the Iriarti patent shows a soft fabric cover with an adhesive on the bottom side which is larger than the resilient band. The resilient band is centered on the bottom of the soft fabric cover and attached to the adhesive. The center of the two-piece nasal dilator is bent over the bridge of the nose, and each end is attached to the soft tissue on the lateral wall of the nasal passage using the adhesive on the soft fabric cover that extends beyond the edge of the resilient band.
The mechanical forces generated by bending the resilient band from its initial planar state to its deformed state with the ends in contact with the lateral wall of the nasal passages result in forces tending to pull out on the lateral wall tissues which stabilize the walls of the nasal passages during breathing. The forces generated by the resilient band may be greater than the available strength of the adhesive which is located in the border of the soft fabric cover that extends beyond the resilient band as discussed in the second Iriarti design. One skilled in the art could combine the two Iriarti designs and add additional adhesive to the bottom of the resilient band which is attached to the bottom of the soft fabric cover and increase the ability of the nasal dilator to resist the mechanical forces generated by the resilient band.
The present invention is an improvement to the nasal dilator design disclosed in the Iriarti patent because it has a resilient band which has a variable spring rate that decreases from the point where the resilient band crosses the bridge of the nose to the point where the resilient band terminates at the lateral wall of the nasal passage.
The present invention also has a concave indent on one side of the dilator and a convex protrusion on the opposite side of the dilator at the center of the bridge of the nose to indicate to the user the proper orientation of the dilator when it is in use.
Another improvement to the Iriarti design is the use of a soft fabric cushion with adhesive on both sides to prevent the resilient band from coming in contact with the user's skin. This soft fabric cushion is the same size as the top soft fabric cover.
Blockage of the nasal passages from swelling due to allergies, colds and physical deformities can lead to breathing difficulty and discomfort. The nasal passages have mucus membranes which condition the air in the nasal passages prior to its arrival in the lungs. If the nasal passages are constricted due to swelling or minor deformities then the alternative is to breathe through the mouth. This means that the air bypasses the mucus membranes, losing the conditioning effects and causing irritation in the throat and lungs. At night, restrictions to breathing through the nasal passages can lead to snoring and/or sleep disturbances. In some cases, the restricted air supply can cause sleep problems brought on by a lack of oxygen.
For people with chronic blockages in the nasal passages, the alternative to correct the problem has been expensive surgery or medication. People with minor deformities and breathing problems brought on by swelling of the walls of the nasal passageways have been turning to various products fitted in or on the nose which claim to open the nasal passages.
The structure of the nose limits the options available for the design of nasal dilators. The nose terminates at the nostril, which has a slightly expanded volume immediately above it known as the vestibule. Above the vestibule, the nasal passage becomes restricted at a point called the nasal valve. At the nasal valve, the external wall of the nose consists of soft skin known as the lateral wall, which will deform with air pressure changes induced within the nasal passage during the breathing cycles. Above the nasal valve the nasal passage opens up to a cavity with turbinates over the top of the palate and turns downward to join the passage from the mouth to the throat.
The external structure of the nose consists of a skin covering over the nasal bones which are part of the skull. This gives the top of the nose a rigid structure at its base. Beyond the rigid nose bones, there is thin cartilage under the skin which is attached to the septum, which in turn contributes to the outside shape of the nose. The septum forms the wall between the two nostrils and may, if it is crooked, contribute to breathing problems.
As an alternative to surgery, the structure of the nose and the current art leave two alternatives for the design of nasal dilators. One alternative is the type of dilator that consists of some type of tube or structure which can be inserted into the nasal passage to hold it in the open position allowing the free passage of air. The disadvantage to this design is that the dilator structure covers up the mucus membranes which condition the air. Also dilators of this design are uncomfortable and can irritate the walls of the nasal passage.
The second alternative is a dilator design as taught by Iriarti where each end that attaches to the external lateral wall of each of the nasal passages has some type of resilient means connecting the ends for developing an external pulling force on the lateral wall causing it to open the nasal passage. This design has the advantage over the first alternative because the nasal passages are not disturbed by an internal insert. This design has limited control over the resilient force on the lateral wall of each of the nasal passages, and the resilient members crossing over the bridge of the nose can cause discomfort.
The present invention is an improvement over the Iriarti design because it redistributes the lifting forces within the resilient band by modifying the spring rate, so that they can provide optimum lift on the lateral walls of the nasal passage and maximum comfort to the user.
The prior art that comes closest to the present invention is nasal dilators with some means for adjusting the spring rate of the resilient band in the nasal dilator. The first is U.S. Pat. No. 5,476,091 to Johnson, which shows two parallel resilient bands of constant width and constant thickness which cross over the bridge of the nose and terminate at the outer wall of each nasal passage. The Johnson patent shows a plurality of notches cut into the top of each end of the resilient band to reduce the spring rate, which in turn prevents the end of the resilient band from peeling away from the skin. Each notch is a single point reduction of the spring rate with the spring rate reduction determined by the depth of the notch.
The second U.S. Pat. No. 5,479,944 to Petruson and the third U.S. Pat. No. Re 35,408 to Petruson cover the same nasal dilator design. In these patents, the nasal dilator is a one-piece molded plastic strip, the ends of which carry tabs for insertion into the nostrils.
The fourth U.S. Pat. No. 5,611,333 to Johnson shows the same concept of single point reduction in the spring rate of the resilient band using the notches shown in U.S. Pat. No. 5,476,091 mentioned above. In addition this patent shows other designs for the resilient band with either holes or slots which are located at the ends of the resilient bands and are designed to reduce the spring rate at a single point to prevent the end of the resilient band from peeling away from the skin.
The fifth U.S. Pat. No. 6,029,658 to Voss shows a beam-shaped resilient band which extends from one side of the user's nose across the bridge of the nose to the other side of the nose. The resilient band is made of plastic and has a varying thickness and width over the entire span. The resilient band exhibits a rigidity increase from the center towards the two respective ends which attach to the sides of the user's nose, which is the exact opposite of what is attained with the present invention.
The sixth U.S. Pat. No. 6,453,901 to Ierulli shows several nasal strip designs where the cover member extends beyond the perimeter of the spring member, including one embodiment in which the strip has some degree of variation in the spring force over a portion of the length of the strip.
There are many other patents describing nasal dilator designs, but none of them teach the advantage of using a resilient band with a means for varying the spring rate to improve the performance of the nasal dilator or reduce the peel forces at the ends of the strip.